Performance Evaluation of OCT and OCT Angiography-based Ocular Measurements (Optical Coherence Tomography) (OCT)

September 13, 2021 updated by: Optovue

Performance Evaluation of OCT and OCTA-based Ocular Measurements

The purpose of this study is to assess performance of measurements of anatomical and vascular structures of the eye based on OCT and OCTA scans in normal subjects and eyes with pathology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tahlequah, Oklahoma, United States, 74464
        • Oklahoma College of Optometry, Northeastern State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Seeing eye doctor for routine or follow-up care

Description

Inclusion Criteria:

  • Normal - No pre-existing conditions.
  • Glaucoma - Diagnosis of glaucoma.
  • Retina - Diagnosis of retinal pathology
  • Cornea - Diagnosis of clinic condition.

Exclusion Criteria:

- Unable to complete required exams.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal
no pre-existing conditions
Device: optical coherence tomography
imaging structural and vascular features of the eye
Glaucoma
diagnosis of glaucoma
Device: optical coherence tomography
imaging structural and vascular features of the eye
Retina
diagnosis of retina pathology
Device: optical coherence tomography
imaging structural and vascular features of the eye
Cornea
diagnosis of corneal condition
Device: optical coherence tomography
imaging structural and vascular features of the eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard Deviation
Time Frame: Day 1
measure of variance
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Optovue

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 200-54611

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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